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临床试验/NCT06591234
NCT06591234进行中(未招募)不适用

A Multicenter Study on the Reliability of Four Ultrasound Measures : the Antero-posterior Diameter , the End-exipratory Area , the Aspect Ratio and the Collapsibility Index of Internal Jugular Vein Evaluated on Images Recorded From Patients Admitted to Four Medicine Departments

Maggiore Bellaria Hospital, Bologna1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年9月5日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
10
试验地点
1
主要终点
Inter-rater reliability of Internal Jugular Vein Ultrasound measures

研究概览

简要总结

The goal of this observational study is to test the inter-rater reliability among a group of ultrasound measurements of internal jugular vein using a group of images, registered in several acoustic views of neck of patients admitted in Medicine Department.

The main questions it aims to answer is: are there differences in recording echographic measurements of the internal jugular vein between different sonographers ?

详细描述

Dear Mrs/s, We intend to carry out medical scientific research in this Centre. It is a study of observation.. This study aims to measure the reliability (variability in recording measurements between two or more operators) of a new method, the ultrasound of a vein in the neck, called the internal jugular vein. This method could be used to better assess congestion (accumulation of fluid in the lung or tissues: vessels and skin) or lack of fluid in the veins, both possible causes of hospitalization.

We are proposing to you to participate in this study because you are hospitalized in the ward and this method allows to understand, together with other elements, the state of "volemia" (the amount of liquids present in your veins).

We decided to carry out this study because we would like to verify if the ultrasound of the internal jugular vein is reliable, that is it can be used by several operators without variations in the measurements . This would allow, after further studies, to use it in clinical practice for the management of people who may need fluid infusion or therapies to increase fluid removal.

The study aims to evaluate the reliability (variability in recording measurements between two or more operators) of ultrasound of a vein of the neck, called internal jugular vein In particular we would like to understand if there is a variability in the execution of the ultrasound of the jugular vein between several operators- doctors simultaneously to the same patient. In fact, this method is not currently used in current clinical practice, but if we demonstrate that it is reliable (ie more operators record the same measurements on the same patient , without variations), after further confirmation studies have been conducted , could be used in clinical practice. Its use could, in our view, improve the management of many situations, as it would allow doctors to understand whether the person examined is suffering from "congestion", that is, accumulation of water in the lungs and tissues or lack of fluids. This would allow the doctor to take appropriate therapies to reduce congestion or increase fluid.

During the hospitalization, on one occasion, will be submitted to an ultrasound examination of the neck on the right , simultaneously by two or three operators (doctors) . Each operator's examination should take about 10-15 minutes. So the time you spend on it should be 20-30 minutes. The examination will be carried out in bed, in his room with the back tilted 45 degrees and the neck slightly turned to the left.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients, admitted to the Medicine Department of Hospital Maggiore in Bologna and eight expert sonographers

排除标准

  • impossibility in providing consent, presence of central venous catheter in the internal jugular vein, thrombosis of the vein

结局指标

主要结局

Inter-rater reliability of Internal Jugular Vein Ultrasound measures

时间窗: From enrollment to the end of recording (within 2 months of starting the study)

We will measure the variability in recording, among 8 sonographers, of 4 Ultrasound measures of Internal Jugular Vein : the antero-posterior diameters, the area, the aspect ratio and the collapsibility index

次要结局

未报告次要终点

研究者

发起方
Maggiore Bellaria Hospital, Bologna
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicola Parenti

MD

Maggiore Bellaria Hospital, Bologna

研究点 (1)

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